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- Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidanceIndustry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
- FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in ChinaThe U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…